Clinical Trial

Evaluation Criteria, Diagnostic Criteria, Surgical Indications, and Establishment of Surgical Standards for "Cerebral Tinnitus Syndrome" Caused by Internal Jugular Vein Stenosis.

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Summary
"Cerebral Tinnitus," also known as "cranial tinnitus," refers to the patient-reported perception of intracranial sounds. It often presents as "Cerebral Tinnitus Syndrome," which includes symptoms such as tinnitus with hearing loss, headaches, a heavy head sensation, blurred vision, neck and shoulder discomfort, sleep disturbances, anxiety, and depression. Due to limited awareness of cerebral tinnitus, patients frequently seek treatment across multiple facilities without success, severely impacting their and their families' lives and work. Xunming Ji and colleagues have pointed out that cerebral tinnitus results from stenosis of the cerebral or internal jugular veins (IJVS), which impairs cerebral venous outflow and the clearance of metabolic "waste," leading to chronic metabolic damage to brain cells. Currently, studies on the diagnosis and treatment of IJVS-induced cerebral tinnitus, both domestically and internationally, are primarily case reports, lacking systematic evaluation, diagnostic, and treatment standards, which significantly impacts patient outcomes. Our project team is the first to establish evaluation criteria, diagnostic standards, surgical indications, and surgical standards for "Cerebral Tinnitus Syndrome." In preliminary work, we performed internal jugular vein (IJV) decompression on 32 cerebral tinnitus patients, resulting in an IJV morphological improvement rate of 84.3%, a blood flow improvement rate of 75.0%, and a cerebral tinnitus syndrome improvement rate of 62.5%. To date, we have completed 88 IJV decompression surgeries, making ours the largest clinical center for such cases worldwide. We continue to refine these standards, notably introducing new intraoperative standards for IJV "release" and "high perfusion,". To validate and further study these standards, this project plans to perform IJV decompression surgery on 107 cerebral tinnitus patients affected by IJVS. We aim to establish a cerebral tinnitus database and develop a cerebral tinnitus evaluation scale to standardize evaluation criteria, diagnostic standards, surgical indications, and surgical standards, ultimately advancing clinical diagnosis and treatment of Cerebral Tinnitus Syndrome
Trial Details
NCT Number NCT07560280
Lead Sponsor Beijing Shijitan Hospital, Capital Medical University
Conditions Jugular Vein Anomaly (Disorder), Diagnostic Self Evaluation, Nerosurgery, Assessment, Self
Enrollment 369 participants
Start Date 2025-05-07
Primary Completion 2029-12-30 (estimated)
Study Completion 2030-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-01